Wednesday, May 28, 2014

The Centers for Disease Control and Prevention (CDC) has officially classified electronic cigarettes as "tobacco products."

In a November 14, 2013 press release, the CDC refers to electronic cigarettes as an "emerging tobacco product." The agency writes: "Emerging tobacco products such as e-cigarettes and hookahs are quickly
gaining popularity among middle- and high-school students, according to
a report in this week’s Morbidity and Mortality Weekly Report."

In a November 15, 2013 MMWRarticle, the CDC refers to electronic cigarettes as a tobacco product. The article is entitled "Tobacco Product Use among Middle and High School Students -- United States, 2011 and 2012," and it describes the use of cigarettes, cigars, snus, dissolvable tobacco, and electronic cigarettes.

In the November 15 article, the CDC redefines current tobacco use to include electronic cigarettes:

"The 2012 NYTS used a three-stage cluster sampling procedure to generate a
cross-sectional, nationally representative sample of students in grades
6–12. This report includes 2011 and 2012 NYTS data to provide an
updated definition of current tobacco use, which now also includes
hookahs, snus, dissolvable tobacco, and electronic cigarettes, to take
into account nonconventional products that are new to the market or are
increasing in popularity; data for these four products were first
collected in 2011."

In its current fact sheet on youth and tobacco use, the CDC also classifies electronic cigarettes as tobacco products.

The Rest of the Story

From a scientific perspective, the CDC's classification of electronic cigarettes as "tobacco products" is unacceptable. Electronic cigarettes are not tobacco products. They contain no tobacco!

In fact, if the CDC is determined to classify electronic cigarettes as tobacco products, then they must also classify nicotine replacement products as "tobacco products," since NRT - like electronic cigarettes - have nothing to do with tobacco other than that the nicotine in it is derived from tobacco. However, there is no tobacco, per se, in NRT or in electronic cigarettes.

While it is true that from a regulatory perspective, the FDA is classifying electronic cigarettes as tobacco products, this is the result of a detailed definition that is intended for regulatory purposes only. In the Tobacco Act, any substance that contains a chemical derived from tobacco is considered to be a tobacco product.

However, from a scientific perspective, electronic cigarettes are clearly not tobacco products since they contain no tobacco.

By referring to electronic cigarettes as "tobacco products" throughout its web site, including multiple press releases and MMWR articles, the CDC is effectively lying to the public about the nature of this product. The CDC is implying that e-cigarettes contain or are derived from tobacco, which is not true.

Furthermore, the CDC has apparently deliberately chosen not to share with readers the truth: that electronic cigarettes are tobacco-free products. Nowhere in its press release or MMWR article does the CDC let readers know that in spite of its classification as a "tobacco product," e-cigarettes are not actually a tobacco product.

As much as I think classifying electronic cigarettes as tobacco products in its surveys is inappropriate, at least I could have some respect for the agency if it were truthful and acknowledged to readers that these products do not contain any tobacco, and so should not be confused with real cigarettes. However, the CDC repeatedly fails to tell the public that electronic cigarettes contain no tobacco.

In fact, the CDC appears to be afraid to acknowledge this truth to the public. I can find no place on its web site that the CDC informs the public of the critical information that e-cigarettes do not contain tobacco and hence are not tobacco products.

This is a huge gift to the cigarette companies because by lying to the public about the true nature of electronic cigarettes, CDC is protecting the cigarette market from potential competition from non-tobacco electronic cigarettes.

It is baffling to me why the CDC continues to wage a campaign of lies and deception. It is even more baffling why the CDC is lying for the purpose of protecting cigarette companies from competition from much safer, non-tobacco-containing products.

Friday, May 23, 2014

An editorial published in the current issue of Addiction recounts the many ways in which tobacco control researchers have been dishonest with the public about the science regarding electronic cigarettes. It then discusses what needs to happen moving forward, and concludes that what is needed is for tobacco control researchers to be honest.

The authors provide several examples of the dishonesty and misinformation being provided by tobacco control researchers, groups, and policy makers.

Their chief example is striking: many tobacco control researchers are referring to electronic cigarettes as "tobacco products." However, e-cigarettes are not tobacco products. They contain no tobacco whatsoever.

The authors write:

"Many publications and statements by researchers, nongovernmental and governmental agencies and the wider mass media mistakenly refer to e-cigarettes as tobacco products. For example, e-cigarettes were referred to as tobacco products in approximately one in four abstracts about e-cigarettes at the 2014 Annual Meeting of the Society for Research on Nicotine and Tobacco in Seattle [1]. The same error can also be found in the peer-reviewed literature and in writing by influential agencies. For example, the US Center for Disease Control and Prevention website states that ‘emerging tobacco products such as e-cigarettes and hookahs are quickly gaining popularity’ [2]. While it is true that the vast majority of e-cigarettes use a nicotine containing solution that is extracted from the tobacco plant, this is similar to nicotine replacement therapies (NRT) and, unlike ordinary tobacco cigarettes,the current e-cigarettes on the market operate with ‘no tobacco, smoke, or combustion’ [3]. Furthermore, although traces of tobacco-specific nitrosamines (TSNAs) have been found in some e-cigarettes, similar traces of TSNAs are present in licensed NRTs [4–7]. This mislabelling is exacerbated by national and international regulations including e-cigarettes in their tobacco regulations or proposing to do so."

The authors conclude with a section entitled "What Needs to Happen?"

Simply put, they argue that what needs to happen is for tobacco control scientists to start being honest, to adhere to good scientific practice, and to guide their conclusions by evidence rather than emotions.

They write:

"We believe that statements from the research community need to be evidence-based. While lively debates help to advance science and policy, adherence to good scientific practice is paramount. We need more rigour and oversight to ensure that interpretation of evidence is guided by data, not emotions, and that strong statements based on weak evidence are avoided. We need those reviewinggrants and research papers, and also those publishing such papers, to be accountable."

The Rest of the Story

I find quite sad that an article needs to be published imploring tobacco control researchers to be honest and rigorous and to use good scientific practice and draw conclusions based on evidence rather than emotions.

Is there any other area of science where the researchers have to be reminded to be honest and rigorous?

While I agree with the editorial, it is quite a condemnation of the current field of tobacco control research.

The methods of the study were as follows: "Individuals were recruited at e-cigarette retail locations in a large
metropolitan city in the midwestern portion of the
United States in July 2013. A total of 159
participants completed a brief 29-item self-report measure that assessed
behaviors
and perceptions of use."

The results were reported as follows: "Increased duration of e-cigarette use was associated with fewer
cigarettes smoked per day and differing patterns of dependence
to e-cigarettes contingent upon smoking history.
Additionally, increased duration of e-cigarette use was associated with
increased
frequency of use; however, this finding became
nonsignificant when current tobacco cigarette use was accounted for,
suggesting
that individuals may increase e-cigarette use
frequency as they decrease cigarette use. Overall, e-cigarette users
tended
to decrease the strength of nicotine in their
e-cigarette products regardless of duration of use."

The Rest of the Story

There are three major findings -- all preliminary -- from this study.

First, in contrast to what Stan Glantz is arguing, dual use does not appear to be an "adverse consequence" of e-cigarette experimentation. Instead, it appears to be a positive effect that results in a substantial reduction in cigarette consumption among smokers who would almost certainly not have quit smoking altogether in the absence of electronic cigarettes.

Second, in dual users, the total amount of nicotine intake declines. The increase in electronic cigarette use over time is accompanied by a concomitant decline in cigarette smoking. Thus, overall nicotine declines.

Third, e-cigarette users tend to decrease the strength of nicotine in their products, leading one to believe that overall levels of addiction to nicotine decline compared to their baseline smoking status.

Combined with previous evidence, these results suggest that the natural history of electronic cigarette use over time is characterized, in general, by:

The bottom line: it appears that the use of electronic cigarettes has tremendous health benefits not only for those who quit smoking, but also for those who become dual users. While it may take longer for these individuals to eventually get off of nicotine altogether, it appears that the switch to e-cigarettes yields a much lower level of nicotine addiction, making it easier, not harder, to subsequently cease using nicotine if they so desire.

One of the main criticisms of electronic cigarettes leveled by its
opponents in the tobacco control movement is that there are many dual
users of e-cigarettes and tobacco cigarettes and that this has adverse
public health consequences.

For example, Stan Glantz argued against electronic cigarettes in a Scientific Americanarticle, claiming that: "We’ve found very high levels of dual use [traditional cigarettes along
with e-cigarette use]. Very few people have switched away from
cigarettes or managed to use them as a bridge to eventually go off
cigarettes."

While Dr. Glantz's statement that few people have switched away from
cigarettes or used e-cigarettes as a bridge to eventually go off
cigarettes was not science-based, but pure speculation, there are now two studies which actually examine the trajectory of electronic
cigarette and conventional cigarette use among a cohort of e-cigarette
users. We are able to empirically examine Glantz's dual use
argument and his claim that very few smokers are using e-cigarettes as a
bridge to eventually go off cigarettes.

The results from these two studies demonstrate that in contrast to the claims
of many anti-smoking advocates, dual use of electronic cigarettes and
conventional cigarettes does not necessarily have adverse public health
consequences. Instead, it appears that for many smokers, dual use serves
as a gateway to decreased nicotine addiction, and perhaps ultimately to smoking cessation.

The results of this study suggest that anti-smoking advocates
such as Dr. Glantz are wrong in asserting that very few smokers "have
switched away from
cigarettes or managed to use them as a bridge to eventually go off
cigarettes." Instead, there appears to be a large number of smokers who
have indeed switched completely from smoking to vaping, and there also
appears to be a large number of smokers who have successfully used
electronic cigarettes as a bridge to complete smoking cessation.

The rest of the story is that dual use is not necessarily a bad thing. In fact, it may for some be a gateway to smoking cessation.

Wednesday, May 21, 2014

A new study published online ahead of print in the journal Addiction provides evidence that electronic cigarettes may have the potential to outperform nicotine replacement therapy (NRT) for self-assisted smoking cessation.

In this cross-sectional study, a sample of adults who smoked at any point in the past 12 months was identified from a national household survey conducted in England between 2009 and 2014. Criteria for inclusion in the study were: (1) having made a serious quit attempt in the past year; (2) having used e-cigarettes alone, NRT alone, or an unaided quit attempt during their most recent quit attempt; and (3) not having used a prescription cessation drug or behavioral counseling during their most recent quit attempt.

Smoking status was then assessed at the time of the interview to determine the rates of successful quitting during the most recent quit attempt, comparing the three groups: (1) e-cigarettes only; (2) NRT only; and (3) no cessation aids. The total sample size was 5,863.

The odds ratio for successful quitting for the e-cigarette group compared to subjects who used NRT was 2.23 (95% confidence interval, 1.70-2.93).

The odds ratio for successful quitting for the e-cigarette group compared to subjects who used no cessation aid was 1.38 (95% confidence interval, 1.08-2.93).

In the above analyses, the authors controlled for level of nicotine dependence.

The study concludes: "Among smokers who have attempted to stop without professional support, those who use e-cigarettes are more likely to report continued abstinence than those who used a licensed NRT product bought over-the-counter or no aid to cessation."

The Rest of the Story

This study provides data to support the hypothesis that among smokers who choose to quit using e-cigarettes or over-the-counter nicotine replacement products (and without behavioral support), the e-cigarettes produce about a two-fold increase in the quit rate.

Readers should be cautioned that this study should not be used to conclude that e-cigarettes are twice as effective as NRT for smoking cessation generally, for reasons explained articulately by Carl Phillips in his commentary on this study.

Perhaps the most useful contribution of this paper is that it readily demonstrates why the approach being used by Stan Glantz to assess the effectiveness of e-cigarettes for smoking cessation is inappropriate and leads to erroneous conclusions.

The main difference between this study and those touted by Glantz as showing that e-cigarettes are ineffective is that unlike Glantz's cited studies, this one actually examines cessation rates among smokers who reported using e-cigarettes for smoking cessation. In other words, Brown et al. included smokers who reported having used e-cigarettes with the intention to quit smoking. In the studies cited by Glantz, smoking cessation rates for all e-cigarette users were examined, even if a smoker just tried a puff of an electronic cigarette to see what all the hype is about.

For obvious reasons, the Glantz approach is the wrong one to take, and the Brown et al. approach is correct. This study demonstrates that when you analyze the data the proper way, it appears that electronic cigarettes -- for the right smokers -- can be an effective smoking cessation tool.

The key qualifier is "for the right smokers." There is a subset of smokers who try electronic cigarettes and find them satisfactory. They may then go on to make a decision to try to quit using e-cigarettes. The results of this study do not imply that if a smoker were "forced" to use e-cigarettes to quit, one would find the same favorable results.

However, from a public health perspective, the relevant question is not what results one would obtain if smokers were forced to use a particular strategy, but what results are obtained when smokers make the choice to use a particular strategy. This is why Stan Glantz's approach is inappropriate.

Ironically, Stan Glantz criticized the study specifically because it examined the effect of electronic cigarettes on quitting among smokers who desired to quit. According to an article in the New York Times: "Stanton A. Glantz, a professor of medicine at the University of
California, San Francisco, said the study’s limitation was that it tried
to measure the effect of e-cigarette use only among smokers who were
trying hard to quit, not all smokers."

By Stan's logic, we should throw out all the clinical trials upon which the established effectiveness of NRT is based because every one of these trials was designed to assess the efficacy of NRT among smokers who used these drugs with the specific intent to quit. Instead, according to Glantz's logic, we should examine the rate of smoking cessation among everyone who has ever used an NRT product. Doing that would lead to the conclusion that NRT is completely ineffective for smoking cessation.

The biggest problem with Stan's approach is that when you examine e-cigarette users who are not using the product to quit, you are introducing a huge sampling bias. For example, why might someone use e-cigarettes, but not to quit? Most likely, the majority of vapers who are using e-cigarettes for a purpose other than cessation are using e-cigarettes to cut down on the amount they smoke. They are likely to derive benefits from smoking reduction. However, they are almost assuredly not going to quit smoking because they are not trying to quit, nor do they have such a desire.

The rest of the story is that if you ask the wrong question, you are going to get the wrong answer. By asking the wrong question about the effectiveness of electronic cigarettes, Dr. Glantz has obtained the wrong answer.

From a public health perspective, the effectiveness of e-cigarettes for smoking cessation must be assessed by examining how effective the product is for smokers who are trying to quit. When you do that properly, this initial evidence suggests that you find out e-cigarettes are a viable smoking cessation aid for a subset of smokers.

The degree to which electronic cigarettes stimulate or depress overall interest in quitting is a separate and empirically answerable question. In fact, evidence from the UK indicates that the spread of electronic cigarettes has been associated with a substantial increase in the desire to quit smoking at a population level.

Tuesday, May 20, 2014

The Tobacco Control Legal Consortium (TCLC) is urging the public to write to the FDA and encourage the agency to strengthen the proposed deeming regulations on electronic cigarettes. In a set of talking points provided by the TCLC, the Consortium attacks the 24-month grace period for the submission of substantial equivalence or new product applications by electronic cigarette products, calling for the removal of this grace period:

"The FDA proposal
would
significantly delay the implementation of premarket review for
newly covered products. Most egregiously, the proposal creates a twenty-four month
provisional period for the submission of tobacco product marketing applications.
Applications
received during the provisional period
enable the
continued marketing of
the product
until the
FDA acts on the application
which may be well
beyond the
twenty-four
month period. A similar loophole was established during the passage of the Act to apply to cigarettes and smokeless products. The FDA received 3,517 applications but three years later has only issued an order removing four products from the market. After the withdrawal of 117 applications, the tobacco companies are still able to market the unapproved products represented by the 3,396 outstanding applications."

The Rest of the Story

As a public health advocate, the position of the Tobacco Control Legal Consortium is perplexing to me. The Consortium appears to be calling for the removal of the 24-month grace period for submission of substantial equivalence or new product applications by electronic cigarette products. If this advice were to be implemented, then the only electronic cigarettes that could remain on the market are those which were actually marketed as of February 15, 2007. This means that 99.9% of the electronic cigarettes currently on the market would have to be taken off the market.

In other words, the TCLC is calling for a virtual ban on electronic cigarettes. The upheaval created by this ban would destroy all but the largest of the electronic cigarette companies, and would essentially deliver the industry to the tobacco companies. However, even the tobacco companies would have to remove their electronic cigarettes from the market until their applications were approved, a process that would likely take many years.

The effects of such a regulation would be to force thousands of ex-smokers back to cigarette smoking. It would also result in thousands of dual users who have substantially cut down on their smoking to return to their pre-vaping cigarette consumption levels. Of course, the net effect of such a policy would be to substantially harm the public's health.

It's not clear to me whether the TCLC has simply not considered the impact of its recommendations or whether the Consortium actually wants to see a de facto e-cigarette ban. Either way, if the FDA adopts these recommendations, it would be a total disaster for the public's health and a great victory for the cigarette market.

Monday, May 19, 2014

Data published last week in the American Journal of Preventive Medicine suggest that the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are doing an effective job of helping protect the cigarette industry. These data show that despite widespread marketing of electronic cigarettes, half of the adult public still thinks cigarettes are no more hazardous than the fake ones.

According to the new study, of adults who are aware of electronic cigarettes, about half (49.3%) believe that cigarettes are no more harmful than e-cigarettes, which contain no tobacco, involve no combustion, and have been shown to have much lower levels of carcinogens and other toxins.

The Rest of the Story

It is remarkable that despite all of the widespread marketing of electronic cigarettes and the claims that these products represent a safer alternative to smoking, the public is still split down the middle as to whether cigarette smoking is any more hazardous than vaping.

These results demonstrate that the public health messages regarding the severe hazards of cigarette smoking (and the safer alternative represented by e-cigarettes) being disseminated by e-cigarette companies are being successfully undermined by opposing messages from the CDC, FDA, policy makers, and other health groups.

This is an ironic reversal from the past, where it was the public health groups sending the anti-smoking messages and the tobacco industry which was undermining those anti-smoking messages.

Instead, in 2014, it is the electronic cigarette companies which are sending the anti-smoking messages and the health groups which are undermining those messages.

This irony is bizarre, but also quite unfortunate, as the undermining of anti-smoking messages from the e-cigarette industry by health groups is contributing to an unhealthy and incorrect perception that cigarette smoking is no worse than vaping. This incorrect perception is no doubt deterring many smokers from quitting or cutting down substantially on their cigarette consumption by trying e-cigarettes. Thus, the efforts of the FDA, CDC, and other health groups are actually aiding the cigarette companies by helping to protect cigarette sales from competition from the fake, non-tobacco variety.

I find it quite ironic that the health groups, including CDC and FDA, are undermining the efforts of even tobacco companies to develop the non-combustible market and shift a proportion of their sales from combustible to non-combustible products. And the CDC and FDA are completely undermining the efforts of the non-tobacco-related e-cigarette companies to promote e-cigarettes over real tobacco cigarettes.

The rest of the story is that in a tragic reversal of the historical functions of public health viz a viz industry, it is now the e-cigarette companies that are attempting to undermine cigarette smoking while the health groups, led by CDC and FDA, are protecting the cigarette market by undermining the anti-smoking messages from the e-cigarette industry.

Moreover, the FDA is poised to undermine industry messages even more by prohibiting these companies from continuing to use anti-smoking messages in their product promotion campaigns (by applying section 911 of the Tobacco Act to electronic cigarettes).

If the Senate truly wants to reduce cigarette smoking and protect the public's health, it will shift its attack from e-cigarette companies which are trying to get the public off tobacco cigarettes and over to the federal government, which is doing everything it can to protect the cigarette market.

Friday, May 16, 2014

In 1994, so many of us in the tobacco control movement, including myself, castigated the chief executive officers of the tobacco companies who testified before Congress that nicotine is not addictive. In fact, some of us went so far as to suggest that these executives should be prosecuted for perjury.

Clearly, those of us in tobacco control believe it is essential that testimony before Congress be accurate, honest, truthful, transparent, and not at all misleading.

Unfortunately, CDC's testimony yesterday before the Senate Health, Education, Labor, and Pensions Committee fell way short of that mark.

Specifically, in describing the benefits of switching from tobacco cigarettes to electronic cigarettes, the CDC called such benefits "hypothetical," thus casting doubt on whether such benefits actually exist.

The CDC stated: "It is not fair to our children to ask them to pay a price
for that for a hypothetical benefit for adult smokers." [emphasis is mine]

The Rest of the Story

In characterizing the benefits of switching to electronic cigarettes as merely "hypothetical," the CDC has misled the Senate and the American public about the clear science on this issue. There is no question that vaping is much safer than smoking. There is therefore no question that smokers who quit smoking by switching to electronic cigarettes are improving their health. In addition, there is clear evidence that smokers who become dual users are also improving their health. Just this week, a study demonstrated that dual users experience substantial improvements in their asthma symptoms. Moreover, there is abundant clinical evidence, both anecdotal and published, that smokers who switch to electronic cigarettes experience substantial improvement in their respiratory health.

Ironically, the truth is actually the opposite of what the CDC suggests. The benefits of switching to electronic cigarettes for adult smokers are quite clear. In contrast, the harms to youth of trying electronic cigarettes are hypothetical because there is no evidence that e-cigarette use leads to cigarette smoking among adolescents. In fact, the present evidence suggests that e-cigarettes may be serving as a partial deterrent to real cigarette use, as the overwhelming proportion of youth regular e-cigarette users are adolescents who have previously experimented with tobacco products and are therefore at high risk of becoming addicted smokers.

There is an abundance of information about electronic cigarette use that we do not know. However, there is one thing that is clear: electronic cigarettes are much safer than the real ones, and smokers who switch to e-cigarettes or even who cut down substantially on their cigarette use by taking up vaping are greatly improving their health. In other words, the benefits of electronic cigarettes for adult smokers are not hypothetical, but well established.

Why would the CDC deceive Congress and the public in this way? Why misrepresent the nature of the scientific evidence on this issue? Why throw dirt in the face of every vaper who has quit smoking and is proud of himself or herself for having improved their health and perhaps saved their life? Why give ex-smokers throughout the country pause about their switch to vaping and perhaps cause them to return to smoking because of doubt over whether they are experiencing any health benefits?

If the benefits of a switch from smoking to vaping are only "hypothetical," then why should vapers continue to vape? Why not just return to cigarette smoking, since there is no proven benefit to their vaping?

The CDC's misinformation to Congress is therefore not only deceptive, but potentially harmful and destructive as well. It certainly undermines the public's well-established appreciation of the severe hazards of cigarette smoking. If there are no known benefits to smokers of switching to electronic cigarettes, then it appears that smoking isn't as bad as we thought.

The rest of the story is that the tobacco executives are not the only ones who have pulled the wool over the eyes of Congress and the public. Sadly, the CDC has added itself to that shameful category.

Am I equating the lies of the tobacco executives with that of the CDC? Of course not. The nature of the deception was very different and so was the motivation beyond the deception (the tobacco companies lied for profit; the CDC is lying because of an apparent underlying ideology, although its ultimate intentions are good ones). However, misinformation is misinformation and if we are going to attack the tobacco companies for deceiving Congress, then we cannot stand by and allow public health groups to mislead Congress without being willing to also criticize them. In fact, public health should be beyond reproach in providing accurate and scientifically supported information to Congress and the public.

Addendum

This may be the most
difficult blog post I have ever written. I was deeply saddened to see the CDC
completely obscure the critical issues surrounding electronic cigarette use by
arguing that the harms being done to adolescents are definite, while the
benefits to adult smokers as being merely hypothetical. In fact, it is exactly
the opposite.

In contrast, I thought
Mitch Zeller presented a well-balanced and evidence-based perspective.

I hope my readers
understand how difficult it is for me to see this. It literally pains me to
see, especially since I once worked at CDC, in the Office on Smoking and
Health, and have a very deep attachment to that office.

However, I also can’t
stand the idea of a public health agency deceiving the Congress and that has to
take precedence over my deep affections for the office that I love.

Second Addendum

I want to emphasize that this position of the CDC's - that the benefits of e-cigarettes are hypothetical but the harms are real - is not new. Dr. Frieden has been saying this for some time and the CDC testimony yesterday merely reflected this long-standing (but wrong) summary of the scientific evidence.

For example, in a CNN interview,
Dr. Frieden concluded that while the reported benefits of electronic
cigarettes -- aiding smoking cessation -- are merely "possible," the
speculated and undocumented potential harms -- such as hooking kids to
smoking -- are "definite":

"I think what we can say basically is they might or might not be able
to help you quit, but there are definite harms that they can cause. And
those definite harms are in different environments. So, if
they get kids hooked on nicotine, that's a really bad thing. If they get
a smoker who would have quit smoking to continue smoking, that's a bad
thing. If they get a smoker who stopped mo smoking and going back to
nicotine addiction and then smoking, that's a bad thing. And if they
re-glamorize the act of smoking, that's a bad thing. So, we have possible benefits and definite harms."

Thursday, May 15, 2014

Yesterday, I explained that the review of electronic cigarettes by Stan Glantz and colleagues published this week in the journal Circulation is scientifically flawed because it draws conclusions about the efficacy of e-cigarettes for smoking cessation from studies that were not designed to measure such effects in the first place. These studies did not examine smoking cessation rates among a cohort of smokers who were identified at baseline as using e-cigarettes with the intention of quitting smoking. Moreover, smokers who use e-cigarettes are likely more heavily addicted to nicotine and may be more resistant to quitting, thus making inferences about cessation effectiveness from these studies inappropriate.

Today, I express my opinion that the use of these studies to draw conclusions about the efficacy of e-cigarettes for smoking cessation is not just unscientific, but dishonest as well.

The Rest of the Story

The rest of the story is that the review article's authors have actually acknowledged that the 5 studies they use to draw conclusions about the efficacy of e-cigarettes for smoking cessation cannot be used to draw conclusions about the efficacy of e-cigarettes for smoking cessation.

Therefore, their use of these studies to draw conclusions about the efficacy of e-cigarettes for smoking cessation appears to me to be knowingly dishonest.

In a separate article published in the same issue of Circulation, these same authors write: "As of March 2014, 5 population-based studies had examined the
relationship between e-cigarette use
and quitting smoking. Because these studies did
not measure whether people were using e-cigarettes as a smoking
cessation
aid or other reasons for use such as to
circumvent smoke-free laws, they did not directly test the efficacy of
e-cigarettes
as smoking cessation aids." [emphasis is mine]

Curiously, however, this knowledge doesn't stop Glantz from using these studies to draw a conclusion about the efficacy of e-cigarettes as smoking cessation aids in his review article. Moreover, his review article omits any mention of the fact that these 5 studies "did not measure whether people were using e-cigarettes as a smoking cessation aid" and that these studies "did not directly test the efficacy of e-cigarettes as smoking cessation aids."

In other words, Glantz has hidden this information from the reader in the review article, even though he felt it was important enough to mention in the other article. In my opinion, this is knowing dishonesty. It is hiding critical information from the reader that would affect the reader's assessment of the validity of the study's conclusions. Moreover, the review article proceeds to do precisely what the other article argues cannot and should not be done with these studies (i.e., draw conclusions about the efficacy of e-cigarettes as smoking cessation aids).

The article purports to review the scientific evidence of the use of e-cigarettes as a smoking cessation aid and it concludes that population-based studies have demonstrated that e-cigarettes inhibit quitting. Specifically, the article concludes as follows: "e-cigarette use in the real world is associated with significantly
lower odds of quitting smoking cigarettes."

The article does mention that a clinical trial of e-cigarettes found that these products were as effective as the nicotine patch, but it then dismisses this result, concluding instead that: "e-cigarettes are not associated with successful quitting in general population-based
samples of smokers."

The Rest of the Story

In my opinion, rather than being an objective scientific review of the literature, this article is little more than a hatchet job on e-cigarettes. The authors clearly have reached a pre-determined conclusion that e-cigarettes are not helpful in smoking cessation and they stretch science beyond recognition in trying to get the published scientific evidence to support this conclusion.

To illustrate this, let's consider the five studies which the authors cite as providing evidence that electronic cigarettes inhibit smoking cessation.

Presumably, these five studies examined the rate of quitting among smokers who used electronic cigarettes in an attempt to quit smoking.

Question: Of these five studies, how many examined the rate of smoking cessation among smokers who were trying to quit using electronic cigarettes?

A. Five
B. Four
C. Three
D. Two
E. One

Sadly, the answer is:

F. None of the above.

The correct answer is actually:

G. Zero.

The rest of the story is that none of these studies examined quit rates among smokers who were trying to quit using e-cigarettes. None of these studies were in fact designed to examine the role of e-cigarettes in smoking cessation in the first place.

Instead, these were all population-based studies of smoking and e-cigarette use that did not even ask smokers using e-cigarettes if they were using them regularly or if they were using them in an effort to quit smoking. Actually, one of the studies did ask smokers if they were using e-cigarettes to quit smoking and the overwhelming majority said that they were not. In other words, many of the smokers in this study were probably just experimenting with, or trying an e-cigarette, and were not regular users of these products.

Moreover, the users of e-cigarettes in the population were likely more addicted to nicotine, making the comparison of their quit rates with those of other smokers inappropriate.

To illustrate how inappropriate the use of these studies are to draw conclusions about the effectiveness of e-cigarettes for smoking cessation, let's look at two of these studies:

1. The Vickerman study

What Stan does not reveal in his review article is that instead of estimating
cessation rates among a cohort of smokers who made quit attempts using
these products, the Vickerman study analyzed cessation rates of a large number of
smokers who had previously tried to quit using e-cigarettes but failed,
and then called a quitline because they had failed and wanted to try
again.
Then, they compared the quit rate among these smokers to that among
smokers without such a history of a failed quit attempt using electronic
cigarettes.

In other words, this study did not estimate quit rates among smokers
trying to quit using e-cigarettes. Instead, it estimated quit rates
among many smokers who were not using e-cigarettes in their quit attempt
at all!

The truth is that many of the electronic cigarette users in the study did not use electronic cigarettes in their quit attempts!
According to data provided in the paper, a full 28% of the sample of
electronic cigarettes did not use these products in their quit attempts.

It should be clear to readers that this study was poorly designed to
investigate the efficacy of electronic cigarettes. The study systematically
sampled a group of quitline callers who were unsuccessful using electronic
cigarettes. These people tried and failed using electronic cigarettes. How do
we know they failed? Because they wouldn’t have had to call the quitline if
they weren’t still smoking. This is clearly a harder core group of smokers and
it is no surprise that their cessation rates were lower after 6-months than the
comparison group. The study tells us nothing about the effectiveness of
electronic cigarettes, other than that they do not work for everyone. In fact, this research is biased in favor of not finding an
effect of electronic cigarettes on smoking cessation.

The truth is that the authors of this study did not intend to examine the effectiveness of e-cigarettes for smoking cessation. They have in fact explicitly stated that their results cannot and should not be used to draw conclusions about the effectiveness of e-cigarettes.

Dr. Vickerman herself explained
that her results do not in any way indicate that electronic cigarettes
are less effective than NRT, stating: "It may be that callers who had
struggled to quit in the past were more
likely to try e-cigarettes as a new method to help them quit. These
callers may have had a more difficult time quitting, regardless
of their e-cigarette use."

Furthermore, the Alere Wellbeing blog states very clearly: "The recently published article by Dr. Katrina Vickerman and colleagues has been misinterpreted by many who have written about it. It was never intended to assess the effectiveness of the e-cig as a mechanism to quit."

2. The Grana study

Stan also fails to reveal in his review that this study, too, does not examine the rate of successful smoking cessation among electronic cigarette users who want to quit smokingor cut down substantially on the amount that they smoke and who are using e-cigarettes in an attempt to accomplish this.

Instead, the study examines the percentage of quitting among all smokers who have ever tried electronic cigarettes - for any reason - in the past month.

A large proportion of the 88 smokers in this study who had tried an e-cigarette may
have simply been trying these products to see what they are like. It is
plausible, in fact probable, that many of these 88 smokers were not
actually interested in quitting or trying to quit with electronic
cigarettes. These products have become very popular and have gained
widespread media attention and it is entirely possible that many of
these smokers simply wanted to see what the big fuss is all about.

It is easy to see how this fatal flaw in the research destroys the validity of the authors' conclusion.

But that isn't the end of the story. If this were simply a bogus
conclusion, then we could simply evaluate the article as being junk
science, dismiss it as bogus, and leave it there. But unfortunately, it
doesn't end there.

Why? Because it is quite apparent from the study itself that the authors knew
that the overwhelming majority of the 88 electronic cigarettes "users"
in their study had little or no interest in quitting and were not using these products as part of a quit attempt.

How do we know this? Because the authors tell us!

In the Table, the authors report that of the 88 e-cigarette "users,"
only 8.0% reported that they were trying to quit at that time (that is,
within the next 30 days). And only 39.8% of the e-cigarette users had
any intention of quitting in the next six months. This means that we
actually know for a fact that the majority of e-cigarette users in this
study were not using these products as part of a quit attempt.

What this indicates is that this is not simply junk science. Rather, it
is a deliberate attempt on the part of the investigators to misuse data.
They are using these data to draw a conclusion about whether electronic
cigarettes are effective in helping smokers quit, yet they are
knowingly drawing upon data from smokers who are using e-cigarettes for
other reasons, who may have simply tried an electronic cigarette once,
and who most definitely were not using these products as part of a current quit attempt.

In other words, 92% of the e-cigarette users in the study were not
trying to quit. We know for a fact that 92% of the e-cigarette users
were not making a quit attempt. And yet the study authors interpret the
data as if these smokers were trying to quit using e-cigarettes, but
failed!

Putting It All Together

Question: When you conduct a meta-analysis of junk science, what do you come up with?

A. A meaningful point estimate of the association between the exposure and the effect.

B. More junk science.

The answer is:

B. More junk science.

This is exactly what Glantz has done in this review. He has thrown together the results of five studies which provide no actual data on whether or not e-cigarettes are effective in quitting smoking. He has misinterpreted the results of these studies, using them to support an apparently pre-determined conclusion that e-cigarettes are ineffective.

Interestingly, Glantz completely dismisses the results of the one study cited in his review which was actually designed to test the effectiveness of e-cigarettes: the Bullen study, which was a clinical trial of electronic cigarettes for smoking cessation. This study found that e-cigarettes were just as effective as the nicotine patch, which is widely recognized as being an FDA-approved, effective smoking cessation aid. However, Glantz simply dismisses this result, which he apparently does not like, in favor of the findings from the five studies which don't actually examine the relevant research question. He twists these studies to produce data which he does like.

It would be a tragedy if policy makers use the conclusions of this
"scientific review" to draw conclusions about the effectiveness of electronic
cigarettes for smoking cessation purposes.

Tuesday, May 13, 2014

According to a new study published in the International Journal of Environmental Research and Public Health, asthmatic smokers who use electronic cigarettes experience an improvement in their asthma symptoms and lung function, even if they remain dual users.

(See: Polosa R, et al. Effect of smoking abstinence and reduction in asthmatic smokers switching to electronic cigarettes: evidence for harm reversal. International Journal of Environmental Research and Public Health 2014; doi:10.3390/ijerph110504965.)

The study examined 18 smokers with significant asthma who switched to electronic cigarettes. Ten of the patients switched completely and 8 became dual users (both smoking and using e-cigarettes). Among the dual users, the average cigarette consumption dropped from 22.4 to 3.9 cigarettes per day.

After one year follow-up, both the ex-smokers and dual users experienced a significant improvement in asthma symptoms and lung function, especially small airways obstruction. Although the improvements in lung function were small, the improvements in asthma symptoms were clinically relevant.

As the authors point out: "Of interest, consistent improvements in subjective and objective asthma outcomes were also observed amongst dual users (i.e., heavy reducers) with no real difference in dual compared to single users by the end of the observation period."

The authors conclude as follows: "By substantially reducing number of cigarettes smoked per day and exposure to their hazardous toxicants, e-cigs may not only improve asthma symptoms and pulmonary function but may also confer an overall health advantage in smokers with asthma. Therefore, e-cig use in asthmatic smokers unable or unwilling to quit should be exploited as a safer alternative approach to harm-reversal (i.e., specific reversal of asthma-related outcomes) and, in general, to harm-reduction (i.e., overall reduction of smoke-related diseases)."

The Rest of the Story

While this study is preliminary because of the small sample size, it demonstrates that for smokers who are unable to quit smoking using traditional therapies, the use of electronic cigarettes may be a viable alternative to help them quit or substantially cut down and might result in improved respiratory health symptoms.

The study is notable because it found that even among dual users, there was a substantial improvement in respiratory health symptoms and a significant increase in several measures of acute lung function, especially small airways flow rates. Thus, the results of this study suggest that dual use of cigarettes and electronic cigarettes might result in respiratory health improvement if the reduction in cigarette use is dramatic, as it was among the dual users in this study.

The study is also notable because it found no adverse effects of electronic cigarettes on respiratory health among the vulnerable subpopulation of asthmatic patients examined.

Electronic cigarettes are not for everyone, and this study was not designed to examine the proportion of smokers who will be successful in quitting or cutting down substantially. However, it does document that among those who are successful in becoming ex-smokers or dual users with substantially lowered cigarette consumption, they will likely experience an improvement in their respiratory health.

This study provides further evidence that vaping is a much safer alternative to smoking.

Monday, May 12, 2014

In an NPRinterview, CDC director Dr. Thomas Frieden claimed that scientific evidence demonstrates that large numbers of ex-smokers are returning to the use of nicotine products by taking up vaping. He also claimed that electronic cigarettes are deterring smokers from quitting.

According to the interview transcript, Dr. Frieden told the public: "I certainly see the theory that they could be helpful and I've heard
some anecdotes about individuals who say they have helped them quit. But
much more importantly is the actuality that right now we're getting
millions of kids experimenting with or using regularly e-cigarettes.
We're getting smokers who are perhaps using them not to quit but to keep
smoking regular cigarettes. We're seeing large numbers of ex-smokers
going back to nicotine products for the first time in years using
e-cigarettes. We're seeing the re-glamorization of smoking as an act.
And we're also seeing potential exposure of nonsmokers, including
pregnant women, to the nicotine in e-cigarette products. So I see
theoretical potential benefits but definite harms occurring."

The Rest of the Story

The rest of the story is that Dr. Frieden continues to fabricate scientific evidence in an apparent effort to demonize electronic cigarettes. I have already reported how he made up scientific evidence that he purported to demonstrate that electronic cigarettes are a gateway to a lifetime addiction to smoking cigarettes. Here, he apparently makes up scientific evidence that large numbers of ex-smokers are returning to nicotine use by taking up vaping. While I follow the electronic cigarette literature extremely closely, I am aware of no studies which have shown that large numbers of ex-smokers are taking up vaping. In contrast, there is much evidence that large numbers of vapers are quitting smoking, and thus becoming ex-smokers.

A recent study from the UK involved a survey of 12,171 adults in February and March of this year. The survey found that 4.7% of ex-smokers were regularly using electronic cigarettes. Among these ex-smokers, 71% reported that they were using e-cigarettes to try to quit smoking and 48% reported that they were using e-cigarettes to try to keep off tobacco products. These data suggest that the overwhelming majority of ex-smokers using e-cigarettes are people who smoked and then quit smoking because of these products, rather than ex-smokers who returned to nicotine use via e-cigarettes.

At any rate, I'm aware of no data demonstrating that a large proportion of vapers who are ex-smokers were drawn back into nicotine product use after having completely quit smoking.

Moreover, there is no evidence that - as Dr. Frieden claims - we're seeing many smokers who are inhibited from quitting because they try electronic cigarettes.

And furthermore, there is no evidence that electronic cigarettes are causing nonsmoking youth to become regular users. In fact, there is no evidence that any substantial proportion of nonsmoking youth who tried these products are continuing to use them regularly (more than once per month).

Finally, there is also no evidence that we are seeing the reglamorization of smoking. In fact, current evidence suggests that electronic cigarettes have led to the deglamorization of smoking and have enticed tens of thousands of smokers to try to get off of cigarettes.

I don't begrudge the CDC for enumerating the potential population-level risks of the introduction of electronic cigarettes to the market. However, I do criticize the agency for fabricating scientific evidence in order to support what is clearly a pre-determined agenda: the demonization of e-cigarettes.

In his column on the Hit & Run blog, Jacob Sullum nicely points out the way in which Dr. Frieden is completely ignoring the multitude of data showing that literally thousands of ex-smokers were able to quit smoking using electronic cigarettes. He continues to call these people nothing but "anecdotes." Sullum also points out that Dr. Frieden is "inventing facts from whole cloth in an effort to portray the
product as a grave threat to public health and a menace to 'our
children.'"

I agree, except that I would characterize the material from which Dr. Frieden is inventing these "facts" not as whole cloth but as cloth full of holes, more like a piece of Swiss cheese.

Friday, May 09, 2014

Earlier this week, I revealed
that a group of U.S. senators is disingenuously pushing for a ban on flavored
e-cigarettes. They are disingenuous because while they pretend to be concerned
about the potential for flavored products to addict youth to nicotine, they
actually supported an exemption for menthol from the cigarette flavoring ban,
and they are taking no action to remove this exemption or to demand that the
FDA ban the addition of menthol to cigarettes.

Today, I reveal that it is not only politicians who are
pulling the wool over the eyes of the public. The national anti-smoking groups
are doing it as well.

In an opinion
piece published in the New York Times,
the president of the American Lung Association – Harold Wimmer – argues that
e-cigarettes are addicting our nation’s kids and serving as a gateway to
tobacco addiction. Based on that alleged “fact,” Wimmer argues that electronic
cigarette flavorings should be banned.

Wimmer writes: “E-cigarette companies have revived some
truly repugnant past tobacco marketing tactics – cartoons, celebrities, candy
flavors and health claims – to promote their unregulated new product. Further,
e-cigarettes are available to kids everywhere – online and in stores. Data from
the Centers for Disease Control and Prevention shows e-cigarette use by
children has doubled in just one year. The extended regulatory delay is
contributing to another generation of Americans’ tobacco addiction. … the
F.D.A. must build on them and propose rules to close the Internet sales
loophole, eliminate candy and fruit flavors that attract kids, and require
companies to alter their products to help reduce tobacco’s lethal toll. Each
day of delay in finalizing this proposal means more newly addicted children and
more disease, death and misery.”

The Rest of the Story

This piece by the American Lung Association is completely disingenuous. First of all, the Lung Association opposed an amendment that would have eliminating the menthol exemption in the Family Smoking Prevention and Tobacco Control Act. Second of all, the Lung Association is not also calling for a ban on flavors in cigarettes that attract kids (i.e., menthol).

If the American Lung Association were sincere in its alleged belief that no nicotine-containing products should have flavors that attract kids, then the first and most important action it would take is to demand an immediate ban on the use of menthol flavoring in cigarettes. Short of that, all of this claptrap about eliminating flavors that attract kids and requiring companies to alter their products to help reduce tobacco's lethal toll is a bunch of crap.

Furthermore, the Lung Association's position is not at all science-based. There is no evidence that electronic cigarettes are contributing to "more disease, death, and misery." In fact, the current evidence suggests that electronic cigarettes are contributing significantly to the reduction of disease, death, and misery.

Like Senator Blumenthal's statement which I discussed yesterday, this piece by the American Lung Association is completely divorced from science and scientific evidence and falls solidly into the realm of political propaganda.

Thursday, May 08, 2014

As I revealed
yesterday, U.S. Senator Richard Blumenthal (D-CT) and a number of his
colleagues are pushing for a ban on flavored electronic cigarettes, which they
say is necessary to protect kids from addiction to nicotine. Senator Blumenthal
is supporting his proposal by purporting to cite scientific evidence that
electronic cigarettes are a gateway to a lifetime of addiction to cigarette
smoking.

As quoted in an article
in the New Haven Register, Senator
Blumenthal stated: “I feel I’m very clearly and immediately in touch with
America but just as important in touch with public health and science, that
shows e-cigarettes can addict children to nicotine and lure them into a
lifetime of smoking addiction and cost our society billions of dollars.”

The Rest of the Story

Far from being in touch with public health and science,
Senator Blumenthal is lying to the public about the science in order to promote
his e-cigarette flavorings ban. The truth is that there is absolutely no
scientific evidence that e-cigarettes addict youth and cause them to transition
into a lifetime of smoking addiction.

In fact, there is no evidence for any of the three parts of
Senator Blumenthal’s statement. There is no scientific evidence that
e-cigarettes addict children to nicotine. There is no evidence that
e-cigarettes lure children into a lifetime of smoking addiction. And there is
no evidence that e-cigarettes cost our society billions of dollars.

With that said, I can’t completely blame Senator Blumenthal
because the CDC has been disseminating the false assertion that its recent
survey demonstrated that e-cigarettes are a gateway to smoking addiction. So it
appears that the lie originated with the CDC and then was adopted by Senator
Blumenthal. He may not be deserving of all of the blame here. The CDC must bear
the responsibility for originating this lie.

Public policy should be evidence-based. This is especially
true for public health policy. If we follow Senator Blumenthal’s lead, public
health policy is going to be formulated based on politics rather than science.

There is certainly room for vigorous debate about the
policies that are appropriate to help protect children from the risks posed by
electronic cigarettes. However, lying about the science has no place in that
debate.

The rest of the story is that by lying to the
public, Senator Blumenthal has introduced politics into the debate and
demonstrated that Congress remains clearly in touch with political motives, not
science-based public health ones.

Wednesday, May 07, 2014

A group of U.S. Congressmembers - including Dick Durbin (D-IL), John D. Rockefeller (D-WV), Richard Blumenthal
(D-CT), Edward J. Markey (D-MA), Sherrod Brown (D-OH), Jack Reed (D-RI),
and U.S. Representative Frank Pallone, Jr. (D-NJ) - are calling for a ban on flavored electronic cigarettes in order to protect youth from "nicotine addiction."

In a salvo of actions, these lawmakers first issued a report decrying the use of flavorings in electronic cigarettes and then criticized the FDA's proposed deeming regulations for not imposing a ban on these flavorings.

The report issued by these lawmakers calls for a ban on flavors in e-cigarettes.

Senator Blumenthal has clearly stated his position: "'I think flavors ought to be banned,' Blumenthal told U.S. News. It's
'completely disingenuous' to say adults are the primary users of popular
flavor options, he said."

The Rest of the Story

Actually, what is completely disingenuous is the attempt of these politicians to pretend that they are committed to ending the use of flavorings to addict youth to nicotine. The rest of the story is that these same lawmakers chose not to ban the use of cigarette flavorings to addict youth to nicotine. Specifically, they have supported an exemption for menthol, which is the number one flavor used by cigarette companies to addict youth to nicotine and cigarette smoking.

Moreover, these politicians - while callling for a ban on flavorings in fake cigarettes - are not calling for a similar ban on all flavorings in real cigarettes. They are not calling for a ban on the use of menthol cigarettes to addict kids. They are not calling on legislation to amend the Family Smoking Prevention and Tobacco Control Act to remove the menthol exemption. They are not calling upon the FDA to ban menthol.

Frankly, these politicians are full of baloney. If they were truly concerned about the use of flavors to addict youth to nicotine and tobacco products, they would not have supported legislation with an exemption for menthol. And more importantly, if they really cared about the health of the nation's youth, they would be calling for an immediate ban on the use of menthol in tobacco cigarettes -- the real ones.

Furthermore, they are lying to the public. In their report, they state: "The Tobacco Control Act restricts the distribution and sale of cigarettes with characterizing flavors." That's not true. After all, the Act does not restrict the sale of cigarettes with menthol as a characterizing flavors. It only prohibits flavors - such as chocolate, vanilla, and strawberry - that were not actually used in cigarettes at the time the legislation was enacted.

The rest of the story is that these Congressmen are insincere and disingenuous. They are also hypocrites. And they are trying to pull the wool over the eyes of the public. This is clearly motivated by a desire for political gain, rather than a sincere interest in protecting the health of the nation's youth.

Tuesday, May 06, 2014

I have already discussed what I believe is the most disastrous aspect of the proposed FDA deeming regulations for electronic cigarettes: the subjection of electronic cigarettes to section 911 of the Family Smoking Prevention and Tobacco Control Act, which will prohibit e-cigarette companies from truthfully marketing their products as a safer alternative to smoking.

Today, I discuss what I see as the second most disastrous aspect of the deeming regulations: the requirement for new product applications for most electronic cigarettes.

The Rest of the Story

The proposed deeming regulations require all electronic cigarette products that are not substantially equivalent to those on the market as of February 15, 2007, and all new products, to submit new product applications. Electronic cigarette products currently on the market have 24 months to submit these applications and can remain on the market until a decision is made on their applications. New e-cigarette products must have their applications approved before they can enter the market.

There are two important issues to consider. First, what products on the market are substantially equivalent to those that were on the market in February 2007? Second, what will be necessary to have new product applications approved?

The answer to the first question depends on exactly how FDA interprets substantial equivalence. However, if it is anything like the way the FDA is defining substantial equivalence for cigarettes, then most of the thousands of electronic cigarette products currently on the market will not meet the definition of substantial equivalence and will have to submit new product applications, rather than substantial equivalence applications.

Substantial equivalence requires that the product raise no new or different issues of public health compared to the predicate product. Since in February 2007, the predicate products were drastically different from most of what is on the market today, it is unlikely that the FDA would find most of today's products to be substantially equivalent to those early products. Remember that e-cigarettes only entered the U.S. market in 2006, so the products on the market as of February 15, 2007 were antiquated by today's standards.

Moreover, even if a brand were nearly identical to a predicate product, if there is any difference in the e-liquids or heating mechanisms, it is most likely going to present different issues of public health. Moreover, without any testing of the chemicals in the vapor of the predicate products available, it will be impossible for most companies to demonstrate that their products fail to present different issues of public health from the predicate product.

In other words, if the FDA stays true to the clear statutory meaning of substantial equivalence, there will be only a few products that can meet this standard.

Therefore, for the bulk of the products on the market, it will come down to a new product application.

New product applications require that the company demonstrate that the product is appropriate for the public's health. This means not only that the product must be shown to be safer than cigarettes for smokers who switch to the product, but also that the product benefits the public's health, taking into account nonusers of the product. Thus, in order to meet FDA approval, you would have to prove that the product
improves health, both on an individual and a population level.

While I believe it would be quite straightforward to demonstrate the individual health benefits of electronic cigarettes over real ones, it is not so trivial to have to demonstrate the overall population-level benefits. To do this, one would have to estimate the proportion of smokers who would switch to electronic cigarettes and the proportion of nonsmokers who would start using the product. One would also have to know the percentage of nonsmokers who would progress to smoking.

The studies required to obtain this information are substantial, and it is doubtful that most smaller companies have the resources to conduct these studies. It is not initially clear to me that any company would be able to meet this regulatory burden. However, if any companies are equipped to do so, it is the tobacco companies and perhaps the largest of the electronic cigarette companies.

The end result of this provision would likely be to contract the market, making fewer choices available to consumers.

But taking a step back, what sense does it make to require new product applications in the first place?

With cigarettes, I can see how new product applications make sense. The tobacco companies had a history of introducing products to the market that appeared safer, but were not. They also had a history of making product changes in order to make cigarettes more addictive. Therefore, it might make some sense to require new product applications for cigarettes.

However, for electronic cigarettes, it makes absolutely no sense. To be sure, the newer products are the safest and the most effective. It is the older products - the antiquated ones - that were much less effective and generally not as safe. With time, product quality has improved, more manufacturing standards have been put in place, better methods have been developed, and safer products have been produced.

For example, early products - such as the ones on the market in 2007 - were found to contain diethylene glycol, an ingredient in anti-freeze. Since that time, I am aware of no testing of any new product which has detected diethylene glycol.

The rest of the story is that the FDA has this all wrong. They are doing the exact opposite of what they should be doing. Instead of requiring new product applications for all the new and improved electronic cigarettes to stay on the market or to enter the market, the FDA should be requiring the older products to demonstrate why they should be allowed to remain on the market. In other words, those old products with diethylene glycol - they should be the ones with some sort of regulatory burden, not the newer products that don't deliver diethylene glycol.

Moreover, this provision will stifle innovation in the e-cigarette market. But innovation is what is going to gradually create safer and more effective products. And innovation is what is going to stimulate demand, thus resulting in an expansion of the market and a continuing decline in combustible cigarette consumption.

The deeming regulations - if adopted as is - would greatly inhibit innovation and constrict the e-cigarette market, reducing the beneficial impact of electronic cigarettes in reducing combustible cigarette consumption.

In this way, the deeming regulations will harm the public's health rather than protect it. Or stated another way, these deeming regulations will result in more deaths than lives saved.

Monday, May 05, 2014

Last November, I reported that CDC was lying to the public by telling us that an agency survey had found that electronic cigarettes are a gateway to smoking. Specifically, I noted that CDC director Dr. Thomas Frieden stated at that time:
"What we are doing first is tracking, and we are seeing some very
concerning trends. Use of e-cigarettes in youth doubled just in the past
year, and many kids are starting out with e-cigarettes and then going
on to smoke conventional cigarettes." However, the CDC was a cross-sectional one and it didn't track e-cigarette users over time to see whether they went on to smoke conventional cigarettes. Thus, Dr. Frieden was lying to the public.

The Rest of the Story issued a call for a corrective statement by CDC to clarify this error, but none was forthcoming.

Instead, in response, a CDC official defended Dr. Frieden by suggesting that the statement was just an inconsequential slip of the tongue.

Today, I reveal that CDC has again lied to the public, which suggests that its dishonesty is not just an inconsequential slip, but a pattern of dishonest behavior intended to demonize electronic cigarettes.The Rest of the StoryIn an article published last week in the Los Angeles Times, CDC director Dr. Thomas Frieden was quoted as stating:

"The challenge that the FDA has is that they will be challenged by the
tobacco industry, as they have been at every step of the way. [The FDA] tried to regulate e-cigarettes earlier, and they
lost to the tobacco industry. … So the FDA has to balance moving quickly
with moving in a way that’s going to be able to survive the tobacco
industry’s highly paid legal challenge."

Assuming that this is an accurate quote from Dr. Frieden, the CDC is lying. It is not true that the FDA lost a lawsuit to the tobacco industry when it tried to regulate e-cigarettes earlier. The lawsuit it lost was filed by two electronic cigarette companies, neither of which were owned by Big Tobacco. In fact, at the time of that lawsuit, the tobacco companies were not even in the business of selling e-cigarettes. All e-cigarette companies at that time were independent of Big Tobacco.

Clearly, this statement by the CDC is intended to imply that Big Tobacco has been fighting the FDA's attempts to first ban and now regulate the product. This is false. In fact, the tobacco companies were not involved in the earlier lawsuit and since entering the market, they have strongly supported the FDA's regulation of electronic cigarettes.

In fact, it is unlikely that the tobacco companies will challenge the deeming regulations. These companies stand to gain the most by the regulations, which make it much more difficult, if not impossible, for the non-tobacco-related electronic cigarette companies (especially the smaller ones) to survive. If the deeming regulations are challenged, that challenge is more likely to come from the smaller manufacturers, not the tobacco companies. And any such challenge would not be from "highly paid" sources, but from companies that cannot independently afford such a challenge. They would have to pool resources to have any chance of affording such a challenge, which makes me believe that any serious challenge to the regulations is unlikely.

If this statement was misquoted by the Times, then the CDC should have immediately corrected it. Since I do not see any correction (as of the time of the writing of this post), I have to assume that the statement is correct.

As I remarked last week, I do not begrudge the CDC for holding a different position than I do on the e-cigarette issue. However, the agency crosses the line when it lies to the public in order to support its position. Dishonesty has no place on the agenda of a federal public health agency, especially one that is as highly reputed as the CDC.

Friday, May 02, 2014

On this Friday afternoon, I want to give a huge shout out to the literally tens of thousands of "anecdotes" out there who have successfully quit smoking via the use of electronic cigarettes.

You may wonder why I am calling these people - smokers who have quit smoking via electronic cigarettes - anecdotes.

The reason is this:

According to CDC Director Dr. Thomas Frieden, the thousands of smokers who have quit smoking via electronic cigarettes are nothing but anecdotes. As Dr. Frieden told the Los Angeles Times in this article, referring to smokers who have quit using e-cigarettes: "the plural of anecdote is not data."

The complete quote from this article:

"Frieden acknowledged that “stick to stick, they’re almost certainly less
toxic than cigarettes" and that many people have quit smoking tobacco
cigarettes with the help of e-cigarettes. However, he said, “the plural
of anecdote is not data.”"

The Rest of the Story

There is one thing you almost never hear most anti-smoking advocates and groups say to smokers who have quit via electronic cigarettes ...... "Congratulations."
I have long found it curious that anti-smoking advocates and groups fail to praise and congratulate vapers who have completely quit smoking for having completely quit smoking. Apparently, in tobacco control, it is not just important to quit smoking, but you have to quit smoking the right way (a.k.a., with Big Pharma drugs).

Today, I'd like to clearly and unequivocally say, as a staunch anti-smoking advocate:

"Congratulations to all the tens of thousands of vapers out there who have quit smoking using electronic cigarettes. You have helped to improve your health and perhaps save your life. You have taken the most important step in improving your health. And you have done a tremendous favor for your family, friends, and loved ones.""Do not listen to what the CDC and the FDA are telling you. There is no question that by quitting smoking, you have greatly improved your health. There is no question that vaping is much safer than smoking. Do not allow yourself to be deceived by the propaganda. Do not return to cigarette smoking in fear that somehow there are hidden risks in vaping that could render them just as dangerous as cigarettes."

"And most importantly, you are not just anecdotes. Each one of you is a real, courageous person who has accomplished one of the most difficult personal struggles that a person can face in terms of health behavior: quitting smoking, one of the strongest and most powerful addictions. Congratulations!"

Incidentally, it is just not true that the plural of anecdote is not data. In fact, a single anecdote is "data." One of the most basic study designs in epidemiology is something called a "case study." That is the "anecdote" about a single individual. The next basic design is a "case series," which is simply a number of "anecdotes."

Some of the most important conclusions in epidemiologic research have come not from large case-control or cohort studies or clinical trials, but from case studies or case series, or as Dr. Frieden would say, "anecdotes."

For example, I am proud of having been part of a team that was the first ever to report that the dietary supplement L-tryptophan can cause pulmonary hypertension via the eosinophilia-myalgia syndrome. This important conclusion - which had major public health policy implications - was based on a single reported case of pulmonary hypertension. In other words, it was based on a single "anecdote." Had we dismissed this finding because a single anecdote is not data, then we would have failed to report this relationship and many more patients would have suffered that fate, possibly leading to fatalities.

Anecdotes are in fact data. Of course, what you do with that data and how you interpret it is affected by the nature of how the data were obtained. But anecdotes are data. Remember, the connection between smoking and lung cancer itself was first uncovered by a case series. Physicians started to note multiple cases of lung cancer - which was very rare at the time - all occurring in smokers. While these patients could be called "anecdotes," they were also people who provided very real and important data that led to the discovery that smoking causes lung cancer. That connection would not have been found had these "anecdotes" been dismissed.

In an article published early this week in the Los Angeles Times, CDC director Dr. Thomas Frieden issues a blistering attack on electronic cigarettes. In the article, he compares the damage and destruction caused by tobacco cigarettes with e-cigarettes, suggesting that another generation of our kids is going to become addicted to smoking because of e-cigarettes. He argues that the electronic cigarette industry is harming "hundreds of thousands of children."

Dr. Frieden is quoted as stating that: "E-cigarettes are a tobacco product."

In addition, Dr. Frieden insinuates that electronic cigarettes are a gateway to smoking, are impeding smokers from quitting, are causing ex-smokers to return to smoking, and deterring smokers who want to quit from quitting.

He states: “If they get another generation of kids more hooked on nicotine and
more likely to smoke cigarettes, that’s more harm than good. If they get smokers who would have quit to keep smoking instead of quitting, more harm than good. If they get ex-smokers who have been off nicotine to go back on nicotine and then back to cigarettes, more harm than good. If they get people who want to quit smoking and would have taken
medicines to think e-cigarettes are going to help, but they don’t, more
harm than good."

Furthermore, the reporter interpreted Dr. Frieden as asserting that "e-cigarettes are as dangerous as tobacco cigarettes."

The Rest of the Story

The rest of the story is simple: the CDC is spreading unsupported propaganda and misinformation to the public as part of an unscientific and unwarranted attack on electronic cigarettes. Sadly, this attack on electronic cigarettes is doing a huge favor to Big Tobacco because it is going to deter smokers who would otherwise have quit or cut down using e-cigarettes from doing so and it may well cause many ex-smokers who quit via electronic cigarettes to return to cigarette smoking.

I do not begrudge the CDC for holding a different position than I do regarding electronic cigarettes. However, I find it abhorrent that the CDC is supporting this position by disseminating false and misleading information that is completely unsupported by scientific evidence. Our nation's leading public health agency should not be acting in this way.

There is absolutely no evidence that electronic cigarettes are a gateway to smoking. There is no evidence that vaping is impeding smoking cessation or that it is causing former smokers to return to smoking. In fact, the existing evidence suggests that the opposite is true: it appears that electronic cigarettes are increasing quitting attempts and enhancing smoking cessation without serving as a gateway to youth smoking.

There is no evidence that the e-cigarette industry is harming hundreds
of thousands of children. Most of the youth who have used e-cigarettes
are those who were already users of tobacco products, so it is entirely
possible that the use of e-cigarettes among these children actually
decreased their tobacco use. Moreover, the assertion that e-cigarettes
are a gateway to smoking is inconsistent with actual data on trends in
youth smoking rates. Furthermore, the assertion that e-cigarettes are
impeding smoking cessation is inconsistent with data on cigarette
consumption trends.

That the CDC has apparently drawn pre-determined conclusions about these questions is both inappropriate and unfortunate. And it is not only unscientific but it precludes the agency from making evidence-based decisions or recommendations.

Even claiming that electronic cigarettes are tobacco products is disingenuous because these products do not contain tobacco. It is true that electronic cigarettes are being regulated as "tobacco products," but they are not tobacco products in the ordinary usage of this term. Calling them tobacco products will mislead the public into thinking that electronic cigarettes contain tobacco. This is of course not true.

While as I said, I do not begrudge the CDC for holding this position on e-cigarettes, the fact that it is resorting to fabricating evidence in support of its position suggests that its position is untenable. If your position is strong, you should be able to support it with actual facts and scientific evidence. When all you can do to support your position is to produce false and misleading propaganda, then it's pretty clear you don't have a leg to stand on.

Thursday, May 01, 2014

I am aware of no consumer product on the market that is prohibited by federal law or regulation from truthfully informing consumers of the primary benefit of that product.

If the FDA goes ahead with its proposal to subject electronic cigarettes to section 911 of the Family Smoking Prevention and Tobacco Control Act, e-cigarettes will become the first such product.

The proposed deeming regulations would immediately prohibit electronic cigarette companies from informing consumers of the following, each of which is true:

that the primary purpose of electronic cigarettes is to provide a safer alternative to smoking;

that electronic cigarettes do not contain any tobacco, and are therefore a tobacco product only in a legal/regulatory sense;

that electronic cigarettes contain much lower levels of tobacco-specific nitrosamines and many other carcinogens than tobacco cigarettes;

that electronic cigarette use is much safer than smoking.

In my view, it is impossible to justify this aspect of the FDA's proposed deeming regulations because any restrictions on marketing to adult consumers should be based on the need to prevent companies from transmitting false, misleading, or deceptive information. Prohibiting companies from telling consumers the truth does not advance any legitimate government interest.

For this reason, I believe there is a serious question as to the constitutionality of this provision of the deeming regulations. The government cannot interfere with commercial speech unless that interference is necessary to promote a legitimate government interest. The only way that the government could show that a ban on stating that electronic cigarettes are safer than tobacco cigarettes advances a legitimate government interest would be to provide evidence that electronic cigarettes are not safer than real cigarettes. Since such evidence does not exist, the government would have a difficult time making the case. Therefore, I believe that if the deeming regulations are promulgated in their current form, this aspect of the regulations will be successfully challenged by the electronic cigarette industry.

I am not aware of any other federal law or regulation that prohibits companies from telling consumers the truth about their products as it relates to the primary benefit of the product. Hopefully, the FDA will see the error in its proposal and will reconsider its decision to subject electronic cigarettes to the provisions of section 911.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.